Effects of Mild Hypobaric Hypoxia on Oxygen Saturation During Sleep

NCT00659009 | Completed

• 1 other identifier: Boeing-003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Ascent to altitude lowers oxygen saturation. In addition, sleep lowers oxygen saturation at any altitude. In a prior study, we observed that sleep at 8000 feet resulted in pronounced reduction in oxygen saturation, but did not result in reduced post sleep neurobehavioral performance or impaired sleep quality or quantity. We plan to do a more sophisticated physiological evaluation of the respiratory mechanisms responsible for the reduced oxygen saturation and determine if there are any adverse consequences to this level of intermittent hypoxia. We anticipate that central respiratory apnea is the physiologic mechanism, and that there will not be persistent changes in autonomic nervous activity measured by heart rate variability.

Conditions

Sleep-related Respiratory Disturbance

Keywords

environmental; hypobaric hypoxia; sleep; respiratory-disturbance; neurobehavioral performance; Effect of altitude on sleep-related respiratory disturbance

Outcome Measures

Primary Outcomes (3)

• SpO2

  Continuous during sleep

• Respiratory Disturbance

  Continuous during sleep

• Sleep architecture

  Continuous during sleep

Secondary Outcomes (1)

• Heart rate variability

  Continuous during sleep and 8 hr following exposure

Study Arms (3)

1

ACTIVE COMPARATOR

Barometric pressure equivalent to sea level (760 mm Hg).

Other: Sea level equivalent barometric pressure

2

EXPERIMENTAL

Barometric pressure equivalent to 6000 feet (609 mm Hg)

Other: Reduced barometric pressure

3

EXPERIMENTAL

Barometric pressure equivalent to 8000 feet (565 mm Hg).

Other: Reduced barometric pressure

Interventions

Reduced barometric pressure OTHER

Sleep in reduced barometric pressure environment.

2

Sea level equivalent barometric pressure OTHER

Sleep in barometric pressure equivalent to sea level.

1

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Between 30 and 60 years of age.
• Healthy, able to pass FAA Class III examination
• Body mass index less than 30
• Height less than 75 inches
• Ability to read and speak English

You may not qualify if:

• Prolonged residence above 5000 feet
• Recent travel to altitudes above 5000 feet
• Use of drugs or medications that affect sleep
• History of mood or psychiatric disorders that affect sleep.
• History of medical conditions that increase risk of adverse effects of hypoxia.
• Apnea hypopnea index greater than 15/hr at ground level.

Sponsors & Collaborators

• The Boeing Company: lead
• Simon Fraser University: collaborator
• Massey University: collaborator

Study Sites (1)

Environmental Physiology Unit, School of Kinesiology, Simon Fraser University

Burnaby, British Columbia, V5A 1S6, Canada

Location

Study Officials

• James M Muhm, MD, MPH

  The Boeing Company

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 16, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 15, 2012

Record last verified: 2010-02

Locations

CA (1)